The Impact of New Laws When Selling Medical Devices to Europe: Part II

Aug 15, 2017 | News

MEDDEV 2.7.1 and what it means for clinical evaluations and reports

If you are a medical device manufacturer planning to sell your devices in Europe, you’re aware by now that there have been significant changes in EU regulations recently that affect how medical devices are brought to market. One key element of these regulatory reforms is MEDDEV 2.7.1 concerning clinical evaluations. Manufacturers must develop a clinical evaluation report:

  • Identify the regulatory requirements that must be supported by clinical data
  • Identify available clinical data that is relevant to the subject device and the state of the art concerning the intended use
  • Determine whether the available data is sufficient to establish the safety and performance of the device
  • Generate additional clinical data as necessary to address any outstanding safety or performance concerns
  • Determine the clinical safety, performance and benefit/risk ratio of the device based on an assessment of all the clinical data collected

There have been important changes that have occurred in the 4th revision

The importance of written procedures

Considering the new European requirements for clinical evaluation and the actions that manufacturers are expected to take to fulfill these requirements, it’s clear that written procedures are critical to facilitate this process and provide consistency in the actions taken. Section 10.2.1, Review of the Manufacturer’s Procedures, advises that the Notified Body should assess the establishment, maintenance and application of the documented procedures for the evaluation of clinical data as part of the review of the manufacturer’s quality system. Readers are advised to review the guidance document for a complete description of areas that the procedures should cover, including:

  • assigning responsibilities to suitably-qualified individuals
  • integrating clinical evaluation into the quality system
  • implementing standard operating procedures to assure proper planning, conduct, evaluation, control and documentation of the various steps of the clinical evaluation process
  • document control
  • identifying and evaluating undesirable side effects the device’s clinical performance as part of the manufacturer’s documented risk analysis, based on both favorable and unfavorable clinical data identified during the clinical evaluation process
  • integration of the Post Market surveillance into the CER updates

Once the clinical evaluation is completed, a CER needs to be developed to describe the scope and context of the evaluation, the clinical data, the appraisal and analysis stages and the conclusions concerning the safety, risk benefit endpoints (Appendix 7.2), and performance of the device in question. For more information see section 7 and Appendix 5 of the MEDDEV. A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of those. There has been an increased emphasis on statistical considerations to demonstrate scientific validity of the clinical data. Section 9.3.1 identifies factors which can affect the validity of the data. Completeness, objectivity and weight of the data during the literature search is also needed, for an appropriate data appraisal and analysis to demonstrate conformity (Sections 8, 9, and 10 and Appendixes 5, 6 and 7).

Probably the biggest change is the Appendix A12.2.3. According the 4th revision of the MEDDEV, A notified Body must prove the manufacturer’s access to equivalent competitor’s data. According to the new Regulations, a manufacturer must have a contract in place allowing access to data for competitor devices with which equivalence is claimed. This is very difficult and thus using equivalent competitor’s data to prove safety, performance and risk-benefit analysis may not be possible.

The new regulations state that this report should contain sufficient information to be read as a stand-alone document by an independent party such as a regulatory authority or Notified Body. If the clinical evaluation report concludes that clinical evidence is insufficient to be able to declare conformity with the Essential Requirements, additional data will need to be generated. As a result, it is necessary to conduct a clinical study or broaden the scope of literature searching to address the deficiency.

Another new point in the fourth revision is the establishment of the term State of the Art. Clause 8.2 provides information with respect to creating and documenting how the product meets state of the art. How manufactures must make sure the Essential Requirements Checklist is up to date and the product meets the latest guidance/Standard revisions. The MEDDEV also states that the device must be compared and benchmarked against competitive devices for risk, benefits and performance.

As we discussed, the new revision is emphasizing risk benefit analysis. There must be an evaluation and quantification of benefits and risks. The evaluation of the overall risk-benefit profile must be based on post-market data, and clinical data. As before, the data must be statistical valid.

Once the initial report is generated, the manufacturer’s responsibility doesn’t stop there. The CER needs to be regularly updated based on ongoing clinical evaluations, or as part of post-market surveillance and vigilance operations. According to Clause 6.2.3, updates to your CER are required every year or when new information is received from post-market surveillance that could affect the current evaluation, or every 2 to 5 years if the device is not expected to pose significant risks and is well established.

Who performs these updates is being scrutinized. According to Clause 6.4 there are specific requirements for the expertise and experience of the reviewers. At least five years of related professional experience plus a higher education degree or at least ten years of related experience if the individuals do not have a higher degree.

Clearly these changes to EU regulations can pose significant challenges to medical device manufacturers. To minimize risk and maximize your ability to gain entry into the European marketplace, contact the EU regulatory experts here at MEDIcept.